Hi everyone,
I learned today about a potential new myeloma treatment that I hadn't heard about before. It's already being tested in a Phase 2 clinical trial. Here is a link to the trial information:
http://clinicaltrials.gov/ct2/show/NCT01478581
The drug is being developed by a company called Pharmacyclics. They are based in California. Here is the company's information page for the drug.
http://www.pharmacyclics.com/clinical_trial_btk_pcyc_pci32765.html
So far, the emphasis seems to have been on developing the drug as a potential treatment for leukemia and lymphoma.
The company website describes PCI-32765 (also known as ibrutinib) as a "selective, irreversible inhibitor of Bruton’s tyrosine kinase (BTK)". It is given orally.
Does anyone know anything else about the drug, or had any experience with it? Are there results of any phase 1 trials with the drug in myeloma that have been published or discussed at conferences?
Forums
Re: PCI-32765 Ibrutinib multiple myeloma trial
I own a bit of the stock and have many hours of research on the company, what would you like to know?
32765 is a super drug, it is better than anything out or being tested. I have posted a link to dr, who is actually in one of the trials. The results are amazing.
the drug works well in most.
[Moderator's note: The link originally included with this posting did not work, so it has been removed.]
32765 is a super drug, it is better than anything out or being tested. I have posted a link to dr, who is actually in one of the trials. The results are amazing.
the drug works well in most.
[Moderator's note: The link originally included with this posting did not work, so it has been removed.]
Re: PCI-32765 Ibrutinib multiple myeloma trial
How about this link, it gives a nice update/overview?
http://www.patientpower.info/video/update-on-kinase-inhibitors-for-cll-where-are-we-now
http://www.patientpower.info/video/update-on-kinase-inhibitors-for-cll-where-are-we-now
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suzierose - Name: suzierose
- When were you/they diagnosed?: 2 sept 2011
Re: PCI-32765 Ibrutinib multiple myeloma trial
Thanks, suzierose. I'm generally not a fan of the patientpower videos, but I'll check this one out since you've recommended it.
Re: PCI-32765 Ibrutinib multiple myeloma trial
My husband took this drug, the first participant in the world post safety trial July 2010. They rushed the approval through as his aggressive, advanced disease was gaining momentum when he arrived at the NCI in Bethesda from half way around the world.
A miracle drug for his DLBCLymphoma ABC subtype. He only had months to live, he had refractory disease from the outset, but only in retrospect did it become obvious why he had little or no response to 11 rounds of escalatingly toxic chemotherapy. Until this paper was published no one knew the significance of this subtype.
April 2010 the first paper was published on the lethal mechanism of this subtype and the proposed BTK Inhibitor. Staudt & Dunleavey at NIH Bethesda. July 2010 it was first administered for the subtype. Within 6 weeks there was a drastic reduction of cancer activity "Dramatic" Dr Louis Staudt said!
When my husband took the drug it just had a number, now it has a name - Ibrutinib. However, as we know cancer can be immortal and only 4/10 on the trial had response, a couple one think has complete response. In our situation the drug gave us 12 weeks of non toxic cancer reduction, so much so that my husband went into a stem cell transplant at NCI in Bethesda.
So for multiple myeloma? all we know is that the drug saved an ABC subtype DLBCLymphoma life, I hope it also has success with other blood cancers. They apparently did find evidence that it had postive effect with other lymphomas.
best of luck from Downunder
A miracle drug for his DLBCLymphoma ABC subtype. He only had months to live, he had refractory disease from the outset, but only in retrospect did it become obvious why he had little or no response to 11 rounds of escalatingly toxic chemotherapy. Until this paper was published no one knew the significance of this subtype.
April 2010 the first paper was published on the lethal mechanism of this subtype and the proposed BTK Inhibitor. Staudt & Dunleavey at NIH Bethesda. July 2010 it was first administered for the subtype. Within 6 weeks there was a drastic reduction of cancer activity "Dramatic" Dr Louis Staudt said!
When my husband took the drug it just had a number, now it has a name - Ibrutinib. However, as we know cancer can be immortal and only 4/10 on the trial had response, a couple one think has complete response. In our situation the drug gave us 12 weeks of non toxic cancer reduction, so much so that my husband went into a stem cell transplant at NCI in Bethesda.
So for multiple myeloma? all we know is that the drug saved an ABC subtype DLBCLymphoma life, I hope it also has success with other blood cancers. They apparently did find evidence that it had postive effect with other lymphomas.
best of luck from Downunder
Re: PCI-32765 Ibrutinib multiple myeloma trial
Hi Joyralph, that is great news. The NIH in Bethesda is such an amazing place. I have just enrolled in their carfilzomib trial for newly diagnosed myeloma. My doctor there, Ola Landgren, is simply amazing and one of the world's leading experts on myeloma and I am lucky to have been offered a spot in the trial. I am watched like a hawk and the team works in almost military precision. I am sure you know what I mean. The results so far for other participants have been reported as excellent. I am impressed that you were able to make it from so far away. Good luck with everything! Terry
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terryl1 - Name: Terry
- Who do you know with myeloma?: self
- When were you/they diagnosed?: August 10, 2011
- Age at diagnosis: 49
Re: PCI-32765 Ibrutinib multiple myeloma trial
Hi Ricardo,
I agree with you about PatientPower videos, they can be hit or miss. What did you think of this one?
I agree with you about PatientPower videos, they can be hit or miss. What did you think of this one?
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suzierose - Name: suzierose
- When were you/they diagnosed?: 2 sept 2011
Re: PCI-32765 Ibrutinib multiple myeloma trial
Some not-so-great news today regarding ibrutinib as a potential myeloma treatment ... The company that has been developing ibrutinib, Pharmacyclics, reported that the drug didn't generate any responses in the initial trial with myeloma patients. The company now plans to test the drug at higher doses.
Here is what they said in the statement::
"We are also reporting on a first, small cohort of multiple myeloma (multiple myeloma) patients. We learned that single agent ibrutinib at 420 mg is tolerable to administer but did not produce defined objective responses (PR, CRs) at this dose. There were, however, several patients that achieved stable disease and minor response. We have expanded the program to understand the drug's response at higher doses (560 mg and 840 mg) and in combination with dexamethasone at the 560 mg and potentially 840 mg dose. As we obtain further data from these cohorts over the next 12 months, we will assess the clinical outcome of ibrutinib in this patient population. At this time, we do not expect to further evaluate single agent ibrutinib at the 420 mg dose in multiple myeloma. "
I guess it's good news that the drug is still going to be tested further in myeloma patients. But it's disappointing that the first trial didn't work out so well.
Here is what they said in the statement::
"We are also reporting on a first, small cohort of multiple myeloma (multiple myeloma) patients. We learned that single agent ibrutinib at 420 mg is tolerable to administer but did not produce defined objective responses (PR, CRs) at this dose. There were, however, several patients that achieved stable disease and minor response. We have expanded the program to understand the drug's response at higher doses (560 mg and 840 mg) and in combination with dexamethasone at the 560 mg and potentially 840 mg dose. As we obtain further data from these cohorts over the next 12 months, we will assess the clinical outcome of ibrutinib in this patient population. At this time, we do not expect to further evaluate single agent ibrutinib at the 420 mg dose in multiple myeloma. "
I guess it's good news that the drug is still going to be tested further in myeloma patients. But it's disappointing that the first trial didn't work out so well.
Re: PCI-32765 Ibrutinib multiple myeloma trial
I think it is important to recognize that most of the patients that enroll in a phase I study like this will have gone through the whole gamut of myeloma therapies that are available prior to enrollment on the study (and there are a lot to choose from, fortunately). Many patients will have disease that is resistant to proteasome inhibitors and the IMiDs (e.g. Revlimid). In addition, many will have cumulative side effects of previous therapy that will make delivery of new treatment more challenging, requiring frequent dose delays and/or reductions. With that in mind, the fact that minor responses were seen and patients achieved stabilization of disease is encouraging. To put it in perspective, the response rate (partial responses or better) to carfilzomib (Kyprolis) in velcade- AND revlimid-resisant myeloma was only 15.4%.
For patients who have lower burdens of disease at relapse and are not suffering from significant morbidity related to their disease, prolonged stabilization of disease and minor responses can be highly meaningful, provided the therapy is well tolerated.
Let's hope the higher dose shows a better signal of activity. In the meanwhile, it will be of paramount importance to better define what makes myeloma refractory to all therapy tick, so we can develop better therapies for this high-risk group of patients.
Pete V.
For patients who have lower burdens of disease at relapse and are not suffering from significant morbidity related to their disease, prolonged stabilization of disease and minor responses can be highly meaningful, provided the therapy is well tolerated.
Let's hope the higher dose shows a better signal of activity. In the meanwhile, it will be of paramount importance to better define what makes myeloma refractory to all therapy tick, so we can develop better therapies for this high-risk group of patients.
Pete V.
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Dr. Peter Voorhees - Name: Peter Voorhees, M.D.
Beacon Medical Advisor
Re: PCI-32765 Ibrutinib multiple myeloma trial
Where can I buy this drug? It is urgently and I need it as soon as is possible. Does anybody knows here can I buy it? If you know, please help me.....
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